CDC and FDA Recommend Suspension of J&J Vaccine Due to Thrombosis

On Tuesday, April 14, the Food and Drug Administration (FDA) asked states to temporarily stop using Johnson & Johnson's Covid-19 vaccine "out of caution" after six women in the United States developed a rare blood clotting disorder, writes CNBC.

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“At this time, these side effects are extremely rare,” the FDA said in a joint statement with the Centers for Disease Control and Prevention (CDC). “The safety of the COVID-19 vaccine is the federal government’s top priority, and we take all reports of health problems following COVID-19 vaccination very seriously.”

All six cases occurred in women between the ages of 18 and 48, with symptoms developing 6-13 days after vaccination. Doctors usually treat this type of blood clot with heparin, but health authorities have noted that it can be dangerous in this case and have recommended a different treatment.

In a statement, J&J said there was no "clear causal relationship" between the blood clots and the vaccine, adding that the company is working closely with regulators to evaluate the data.

People who receive the vaccine "who develop severe headache, stomach pain, leg pain, or shortness of breath within three weeks of vaccination should contact their doctor," the FDA and CDC said.

On the subject: Dozens of people die in the US after being vaccinated against COVID-19

Following the news first reported by The New York Times, J&J shares fell 2,4% in the premarket.

The CDC will convene a meeting of the Immunization Practices Advisory Committee to further review the cases, federal health regulators said. The FDA is also investigating cases.

The J&J vaccine, like the Pfizer and Moderna vaccines, has received FDA approval for emergency use to begin distribution in the United States. A conditional authorization is issued based on safety data two months before another application for full approval is filed, which usually requires at least six months.

J&J submitted data on the Covid vaccine to the FDA in February, and according to the agency, no particular issues were identified at the time when analyzed by age, race, and comorbid conditions. The FDA said the most common side effects at the time were headache and fatigue, followed by muscle aches, nausea, and fever.

It is unclear how this pause will affect J&J's goal of delivering 100 million doses to the United States by the end of May. The company has already run into production problems after the Emergent BioSolutions plant spoiled 15 million doses of the vaccine.

Last week, the European drug regulator said it had found a possible link between the coronavirus vaccine developed by AstraZeneca and the University of Oxford and rare blood clotting problems. AstraZeneca has not been approved for use in the United States.

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Emer Cook, executive director of the European Medicines Agency, said in a televised press conference last week that an unusual blood clotting with low platelet counts would be added as a "very rare" side effect to the product information for the AstraZeneca vaccine, among many others. other possible adverse reactions.

The J&J and AstraZeneca vaccines use adenovirus, a common type of virus that typically causes mild cold symptoms.

As ForumDaily wrote earlier:

• In March, the vaccination process with a vaccine developed by AstraZeneca and the University of Oxford was suspended In several countries in Europe and Asia after reports of thrombus formation in some vaccinated people. However, many countries have defended the use of the vaccine and said they will continue their vaccination campaigns.
• April 10 four states suspended the use of the vaccine Johnson & Johnson due to massive severe side effects.

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